HUP0301131A2 - Method for reducing or eliminating smoking - Google Patents

Abstract

The subject of the invention is a method for gradually reducing or eliminating a person's smoking habit. The invention is characterized by the fact that one unit of alternative nicotine source is first applied for one unit of time after waking up, one unit of time is waited, and then the person continues his smoking habit for a first, predetermined period of time. A unit would then apply an alternative source of nicotine for consecutive time units after awakening, then continue the person's established smoking habit for a first, predetermined period of time to develop a modified smoking habit. The second step is repeated until the desired level of use of the alternative nicotine source and a desirable modified smoking habit are achieved, and then the desired level of use of the alternative nicotine source and the desired modified smoking habit are maintained. The desired level of use of the alternative nicotine source is zero and the desired modified smoking habit is non-smoking. An alternative source of nicotine can be any substance that contains nicotine and delivers a nicotine dose that is close to the amount of nicotine consumed by cigarettes or other tobacco products orally, systemically, through the mucous membrane or in another way. HE

Description

75.218/DE

S. B. G. & K.

Patent Attorney's Office H-1062 Budapest, Andrássy út 113. Telephone: 461-1000, Fax: 461-1099

PUBLICATION

EXAMPLES 1

PROCEDURE TO REDUCE OR CANCEL SMOKING

Background of the invention

The present invention relates to a method for gradually reducing or eliminating a person's smoking habit, particularly smoking associated with fumigation, and nicotine addiction associated with smoking.

The use of smoking cessation strategies has been a focus of research for the past two decades in the development of smoking cessation strategies. However, smoking cessation as a goal or as a means to cessation has received little attention in recent years. In fact, these strategies were not included in the Agency for Health Care Policy and Research (AHCPR) authoritative review (Centers for Disease Control and Prevention, Smoking Cessation Guideline), which sets the standard for treatment of smoking cessation. See U.S. Department of Health and Human Services, AHCPR Publication No. 96-0692, April 1996.

There is a great lack of new treatments for smoking reduction and cessation. Most smoking control interventions are cessation methods and are used without pharmacological or behavioral therapy, partly because the cessation process associated with such therapies does not correspond to the smoking cessation process preferred by smokers. A recent study of smokers' attitudes toward quitting shows that, as opposed to abrupt cessation, many smokers who want to quit prefer to gradually reduce their smoking. Recent studies show that gradual cessation strategies can be successful without pharmacological therapy. However, these strategies include intensive behavioral intervention, and their goal is always to stop smoking, not just reduce it. See, for example, Cinciripini et al., “The Effects of Smoking Schedules on Cessation Outcome: Can We Improve on Common Methods of Gradual and Abrupt Nicotine Withdrawal,” Journal of Consulting and Clinical Psychology, vol. 63, no. 3, pp. 388-399 (1995), which compares two gradual-reduction cessation procedures with abrupt cessation. The gradual-reduction procedures described by Cinciripini et al. involve 1) gradually increasing the intervals between cigarettes smoked and 2) gradually reducing the number of cigarettes smoked without reducing the intervals between cigarettes smoked. Each procedure includes cognitive-behavioral, relapse prevention training, and avoids pharmacological therapy, such as an alternative source of nicotine.

These efforts to achieve cessation through gradual reduction without nicotine replacement often fail. One reason for the failure of the gradual reduction approach is thought to be that smokers are subjected to progressive nicotine withdrawal and therefore experience nicotine craving and withdrawal, which inhibits smoking cessation or further reduction.

U.S. Patent No. 5,055,478 • 4 describes a method that combines reduction with nicotine replacement therapy. In one embodiment, the method described in the patent first records the times during which individual cigarettes were smoked over a period of about two weeks. These smoking periods are called consumption periods. They do not necessarily coincide in time. Consumption is then gradually reduced by replacing more and more consumption periods (up to 16) over a two-week period with an alternative nicotine source, such as Nicorette nicotine-containing chewing gum (2 mg nicotine content), until no more tobacco is consumed. The nicotine in each chewing gum replaces all the tobacco that was consumed during a consumption period. This level of consumption of the alternative nicotine source is maintained for about four weeks. During this four-week period, while the person is still getting nicotine from the alternative nicotine source, the social and psychological causes of smoking are addressed. After the four-week period, the alternative nicotine source is reduced by one consumption period per week for approximately 14-16 weeks until no more alternative nicotine sources are consumed.

Another method described in U.S. Patent No. 5,055,478 begins by recording the person's usual tobacco use for about two weeks to determine the periods of time during the day when tobacco is consumed and the amount of tobacco consumed during those periods. Each day is then broken down into one-hour periods of consumption, followed by abrupt cessation of tobacco use and use of an alternative nicotine source (about 1.5-1.75 mg/consumption period) for about two weeks. As in the above method, after cessation of cigarette smoking but while still using the alternative nicotine source, the person addresses the social and psychological reasons for smoking. The person then gradually reduces the use of the alternative nicotine source to a lower level of about 1 mg/consumption period over a period of 10-18 days. This is accomplished by using the lower dose of the alternative nicotine source in more and more smoking periods until the lower dose is used in all smoking periods. Once the lower dose is used in all smoking periods, the lower dose of the nicotine source is used for approximately two weeks. The subject is then gradually weaned off the alternative nicotine source by phasing out the nicotine source in more and more smoking periods (one per week) until no more nicotine is used. A method very similar to the method of the United States Patent No. 5,111,111, combines cigarette smoking reduction with the use of nicotine replacement therapy. This method is described by Cooper et al. (New Hope for Heavy Smokers - the Cooper/Clayton Method to Stop Smoking). In this method, after an initial two-week data recording period, all smoking periods are replaced with an alternative nicotine source and the subject immediately stops smoking. The rest of the process is similar to the above process, but the alternative nicotine source is reduced to a maintenance level, which is approximately one-third of the initial maintenance level, and then

In the final phase, consumption is gradually reduced as described above. In this procedure, the person maintains close personal contact during the psychological intervention.

SmithKline Beecham's publication, the "Nicorette® Committed Quitters™ Calendar and Smoking-Cessation Service" describes another method. In this method, the person stops smoking abruptly and chews one Nicorette® gum (2 or 4 grams, generic name: nicotine polacrilex gum) every 1-2 hours, up to a maximum of 24 pieces per day, for six weeks. In the seventh week, the person reduces the dose to one piece of Nicorette gum every two hours and maintains this level for three weeks. In the 10th week, the dose is reduced to one piece of Nicorette gum every four hours. After the 12th week, the person stops using Nicorette gum. During the twelve-week period, the person records how many pieces of Nicorette gum they have chewed and plans an activity for each day that will help them cope with not smoking. The calendar-like publication provides helpful advice on nicotine cravings and to address the psychological aspects of quitting smoking and to remind you of the time invested in quitting.

Summary of the invention

The present invention is an improved method for gradually reducing or eliminating smoking, particularly smokeless tobacco smoking, and nicotine dependence associated with smoking, by gradually reducing a person's smoking over a period of time while replacing nicotine from tobacco with an alternative nicotine source.

Detailed description of the invention

The present invention described herein is a method for reducing or eliminating a person's smoking habit, particularly smoking by smoking, and the nicotine dependence associated with the habit. The method involves gradually reducing tobacco use over a period of time until the person significantly reduces or stops smoking. Smoking reduction or cessation may be achieved with or without behavioral intervention, nicotine replacement therapy, such as the use of an alternative nicotine source, by gradual smoking reduction. This strategy extends nicotine replacement therapy from abrupt cessation of smoking to gradual reduction. Gradual reduction in the number of cigarettes smoked or consumption of other nicotine products while replacing nicotine from tobacco with an alternative nicotine source helps to reduce nicotine cravings and nicotine withdrawal, thereby facilitating smoking reduction or cessation.

An alternative nicotine source can be any substance that contains nicotine and delivers a nicotine dose, orally, systemically, transmucosally or otherwise, that is close to the amount of nicotine delivered by cigarettes or other tobacco products. Examples include a suppository, nasal spray, inhaler, nasal spray, lozenge, candy, etc. A preferred alternative nicotine source is nicotine-containing chewing gum, such as nicotine polacrilex chewing gum, which is a form of nicotine-containing

It is preferably contained in a dose of about 2-4 mg.

Preliminary research using the present invention provides clinical evidence that the present invention is effective in reducing smoking in smokers and, when used in a smoking reduction regimen, is more effective than placebo in helping smokers quit smoking.

In one embodiment of the present invention, the following instructions are provided to the smoker for use of nicotine chewing gum (2 or 4 mg dose):

a) On the first day, chew a piece of nicotine gum upon waking, then wait an hour before smoking. After one hour, smoke as much as you need for the rest of the day.

b) On the second day, chew one piece of nicotine gum for each of the first two hours after waking up. Then smoke as much as you need for the rest of the day.

c) Each subsequent day, chew one piece of nicotine gum every hour, one hour longer than the previous day, and then smoke as needed, not to use more than 24 pieces of gum per day.

After four weeks, the person is smoke-free, but continues to use nicotine gum according to the following regimen to prevent nicotine cravings:

a) During weeks 5-10, the person uses a nicotine-containing gum every 1-2 hours.

b) During weeks 11-13, the person uses a nicotine-containing gum every 2-4 hours.

c) During weeks 14-16, the person uses a nicotine-containing gum every 4-8 hours.

d) After week 16, the person stops using nicotine gum unless they need it to keep from smoking.

The efficacy of the method of the present invention, which is a method of gradual reduction to smoking cessation and helps the smoker to gradually reduce the number of cigarettes smoked per day, was demonstrated in a multicenter, randomized, double-blind, placebo-controlled, parallel group study. In this study, nicotine polacrilex chewing gum (2 mg or 4 mg dose) was administered to smokers who met the study criteria. Smokers were randomized approximately equally to the 2 mg and 4 mg dose groups (active and placebo). The subjects themselves selected the dose of chewing gum (2 mg or 4 mg dose group) in Study 1. The study personnel did not provide any advice or intervention. The subjects returned for examination on Day 1, Weeks 2, 4, and 8, and if they were successful in quitting, Week 24. Subjects were given 8 weeks to reduce and stop smoking. We defined abstinence as a person who had been smoke-free for 28 consecutive days and had an average of two carbon monoxide measurements less than or equal to 10 ppm after 2 p.m. at the individual follow-up visit. Subjects participated in the study for up to 6 months. Smoking and chewing gum were recorded on days 1, 2,

We documented this by questionnaire at weeks 4 and 8, and at the individual follow-up visit, if applicable. After two weeks, smoking reduction was measured by the number of cigarettes smoked per day, carbon monoxide levels, and, at selected centers, serum thiocyanate levels.

Subjects used the gum according to the guidelines described above. The Cochran-Mantel-Haenszel test, controlling for site, was used to compare the rates of smoking cessation in the two treatment groups, separately for smokers who chose the 2 mg or 4 mg nicotine gum. The Cochran-Mantel-Haenszel test (general association version) was used to compare the rates of smoking cessation in the two treatment groups, for all smokers, by dose level of nicotine gum.

A total of 3297 subjects were randomized into the two treatment groups as follows:

2 mg group 4 mg group Total: 1636 Total: 1661 Placebo: 817 Placebo: 830 Active: 819 Active: 831

In the 2 mg group, the success rate differed significantly between active (10.38%) and placebo subjects (5.39%). Subjects who received 2 mg of active nicotine gum were almost twice as likely to quit as subjects who received placebo gum. In the 4 mg group, the success rate differed significantly between active (10.60%) and placebo subjects (2.53%). Subjects who received 4 mg of active nicotine gum were four times more likely to quit smoking than those who received placebo gum.

The present invention also provides a method of reducing smoking that does not necessarily lead to cessation of smoking. In this embodiment, when the person reaches the desired smoking level, he continues to use the required amount of tobacco while also using a given level of nicotine-containing chewing gum. For example, if the person reduces his dose to four cigarettes per day and chews twelve pieces of nicotine-containing chewing gum per day, he can maintain this regimen. Of course, this alternative embodiment does not exclude that the ultimate goal is to first reduce smoking and then immediately continue the method described in the first embodiment, or to maintain the reduced regimen for a while and then continue the method according to the first embodiment to stop smoking.

The methods described above are particularly suitable for modern smoking habits, which are shaped by low tolerance for smoking and which can be found, for example, in smoke-free workplaces. The changing social perception of smoking has led smokers to resort to tobacco less frequently and often in unfriendly environments. The steadily increasing use of an alternative nicotine source in the above methods dulls the nicotine craving that naturally occurs during smoke-free periods. The reduced nicotine craving allows the person to stick to the plan more easily than if they were to eliminate tobacco completely or only use an alternative nicotine source in separate periods of consumption.

The methods of the present invention are also intended to be used to reduce and/or discontinue the use of tobacco products other than cigarettes, for example, smokeless tobacco, such as chewing or snuffing tobacco.

When using the present invention as an alternative nicotine source with nicotine-containing chewing gum, the individual should understand and be aware that the nicotine-containing chewing gum is a pharmaceutical product and must be used in a certain manner in order for the nicotine-containing chewing gum and the present invention to exert their beneficial effects. For example, the nicotine-containing chewing gum should be chewed slowly until the individual feels a stinging sensation. The individual should then hold the chewing gum to the face until the stinging sensation is almost gone. If the stinging sensation ceases, the chewing gum should be chewed again until the stinging sensation returns, and then the chewing gum should be stopped again. This process should be repeated until a significant portion of the stinging sensation has disappeared, and then the chewing gum should be discarded.

In the use of the methods of the present invention, subjects were not given detailed instructions, but were given simple, written instructions to follow the steps outlined above. We have found that the present methods overcome the obstacles inherent in previous methods by demonstrating the effectiveness of nicotine replacement therapy in the gradual reduction or cessation of smoking without the intensive, personal involvement of a counselor or psychologist.

The above description of the present invention is for illustrative and explanatory purposes. It is not intended to be exhaustive or to limit the present invention to the precise embodiments and steps disclosed. In light of the above teachings, obvious modifications or variations are possible. For example, the lengths of the various steps of the methods may be varied to accommodate differences in individual smoking habits. Alternative nicotine sources may further include materials that are equivalent to or approximate nicotine, including any and all known compounds and/or compositions, such as lobeline sulfate, which have similar physiological effects and can be used as an alternative nicotine source in the context of the present invention. The above embodiments have been selected and described to best illustrate the principles and practical application of the present invention so that one of ordinary skill in the art may employ the invention in various embodiments and with modifications as appropriate to the particular application. All such modifications and variations are intended to fall within the scope of the present invention as defined by the following claims, when they are interpreted as broadly as they are legally entitled to.

Claims (28)

PATENT CLAIMS 1. A method for gradually reducing or eliminating a person's smoking habit, characterized by a) one unit of an alternative nicotine source is applied for one unit of time after waking up, one unit of time is waited, and then the person resumes their usual smoking habit for a first, predetermined period of time; b) administering a unit of an alternative nicotine source for consecutive time units after awakening, and then having the person continue their current smoking habit for a predetermined period of time to develop a modified smoking habit; repeating step b) until the desired level of use of the alternative nicotine source and a desired modified smoking habit are achieved; we maintain the desired level of use of the alternative nicotine source and the desired modified smoking habit. 2. The method of claim 1, characterized in that the desired level of use of the alternative nicotine source is zero and the desired modified smoking habit is non-smoking, and the number of units of the alternative nicotine source used is gradually reduced by successively a) administering one unit of the alternative nicotine source every one to two time units for a second, predetermined period of time; b) administering one unit of the alternative nicotine source every two to four time units for a third, predetermined period of time; c) administering one unit of the alternative nicotine source every four to eight time units for a fourth predetermined period of time; d) we eliminate the use of the alternative nicotine source. 3. The method according to claim 1, characterized in that the time unit is one hour. 4. The method of claim 2, wherein the second predetermined period is substantially five weeks long. 5. The method of claim 2, wherein the third predetermined period is substantially three weeks long. 6. The method of claim 2, wherein the fourth predetermined period is substantially three weeks long. 7. The method of claim 1, wherein the alternative nicotine source is absorbed through the mucosa. 8. The method of claim 7, wherein the alternative nicotine source is nicotine-containing chewing gum. 9. The method of claim 8, characterized in that the unit of the alternative nicotine source is 2-4 mg. 10. The method of claim 7, wherein the alternative nicotine source is a nicotine-containing inhaler. 11. The method of claim 7, wherein the alternative nicotine source is a nicotine-containing lozenge. 12. The method of claim 7, wherein the alternative nicotine source is a nicotine-containing nasal spray. 13. A method for gradually reducing or eliminating a person's smoking habit, characterized in that a) one unit of nicotine-containing chewing gum is applied for a time unit after waking up, one unit of time is waited, and then the person continues his/her usual smoking habit for a first, predetermined period of time; b) one unit of nicotine-containing chewing gum is administered for consecutive time units after awakening, and then the person continues their established smoking habit for a predetermined period of time to develop a modified smoking habit; repeating step b) until the desired level of nicotine-containing chewing gum use is zero and a desired modified smoking habit is achieved; we maintain the desired level of nicotine gum use and the desired modified smoking habit. 14. The method of claim 13, wherein the desired level of nicotine-containing chewing gum use is zero and the desired modified smoking habit is non-smoking, and the number of units of the alternative nicotine source used is gradually reduced by successively a) administering one unit of the nicotine-containing chewing gum every one to two time units for a second, predetermined period of time; b) administering one unit of the nicotine-containing chewing gum every two to four time units for a third, predetermined period of time; c) administering one unit of the nicotine-containing chewing gum every four to eight time units for a fourth predetermined period of time; d) we will stop using nicotine-containing chewing gum. 15. The method of claim 13, wherein the time unit is one hour. 16. The method of claim 14, wherein the second predetermined period of time is substantially five weeks long. 17. The method of claim 14, wherein the third predetermined period is substantially three weeks long. 18. The method of claim 14, wherein the fourth predetermined period is substantially three weeks long. 19. The method of claim 13, wherein the nicotine-containing chewing gum is absorbed through the mucous membrane. 20. The method of claim 13, wherein the unit of nicotine-containing chewing gum contains about 2-4 mg of nicotine-containing source. 21. The method of claim 1, wherein the smoking is smoking involving fumigation. 22. The method of claim 2, wherein the smoking is smoking involving fumigation. 23. The method of claim 13, wherein the smoking is smoking involving fumigation. 24. The method of claim 14, wherein the smoking is smoking involving fumigation. 25. The method of claim 1, wherein the smoking is the use of a form of smokeless tobacco. 26. The method of claim 2, wherein the smoking is the use of a form of smokeless tobacco. 27. The method of claim 13, wherein the smoking is the use of a form of smokeless tobacco. 28. The method of claim 14, wherein the smoking is the use of a form of smokeless tobacco. The authorized person: